Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT04391985

Collaborator

(none)

113

Enrollment

Location

Arms

Actual Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Virus Infection	Drug: SOF plus (OBV/PTV/r) plus RBV	Phase 1/Phase 2

Detailed Description

Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level < 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Study Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Oct 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cirrhotic Participants The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated for 12 weeks.	Drug: SOF plus (OBV/PTV/r) plus RBV They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability. Other Names: Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Sovaldi is a trade name of sofosbuvir Ombitasvir (ABT 267) is an NS5A inhibitor
Active Comparator: Non-cirrhotic Participants The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks.	Drug: SOF plus (OBV/PTV/r) plus RBV They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability. Other Names: Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Sovaldi is a trade name of sofosbuvir Ombitasvir (ABT 267) is an NS5A inhibitor

Arm

Intervention/Treatment

Active Comparator: Cirrhotic Participants

The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated for 12 weeks.

Drug: SOF plus (OBV/PTV/r) plus RBV

They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.

Other Names:

Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease

Sovaldi is a trade name of sofosbuvir

Ombitasvir (ABT 267) is an NS5A inhibitor

Active Comparator: Non-cirrhotic Participants

The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks.

Drug: SOF plus (OBV/PTV/r) plus RBV

Other Names:

Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease

Sovaldi is a trade name of sofosbuvir

Ombitasvir (ABT 267) is an NS5A inhibitor

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm [12 weeks after last dose]
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/ml 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm [Screening up to 12 weeks after last dose]]
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity

Secondary Outcome Measures

Percentage of Participants With Viral relapse [Up to 12 weeks after last dose]
Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).
The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 > 3.25 (advanced fibrosis or cirrhosis), albumin < 3.5, total bilirubin > 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.

Exclusion Criteria:

liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV
poorly controlled diabetes (HbA1C > 8)
participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study
renal failure
evidence of hepatic decompensation
blood picture abnormalities such as anemia (hemoglobin concentration of < 10 g/dL)
thrombocytopenia (platelets count < 50,000 cells/mm3).
major severe illness such as congestive heart failure and respiratory failure.